Severity 2 of 5
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.
The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.
Siemens Medical Solutions USA Inc. is recalling two Biograph 64-4R CT systems because they may be missing a locking ring on optional ceiling mounts.
The Apothecary Shoppe LLC is recalling SIU-Tri-Mix 30/1/20 Injectable in Oklahoma due to a lack of documentation ensuring proper environmental monitoring during production.
The Apothecary Shoppe LLC is recalling SIU-Tri-Mix 18/1/10 Injection because proper environmental monitoring documentation was missing during production.
Paleteria La Jalpita is recalling 1,890 units of Rompope bolis in Oregon and Washington due to undeclared Yellow No. 5.
Ranbaxy Inc. is recalling 9,229 boxes of Absorica LD (isotretinoin) capsules because the capsule shells contain undeclared FD&C Yellow No. 5.
The Apothecary Shoppe LLC is recalling SIU-Tri-Mix 20/1 mg/10 mcg/mL vials because proper environmental monitoring documentation was missing during production.
Siemens Medical Solutions is recalling two Biograph mCT X-4R systems because they may be missing a locking ring on optional ceiling mounts.
MedOp Health, Inc. is recalling MaxiFlex Multinutrient Formula dietary supplements because a material review found the Chondroitin Sulfate raw material used was out of specification.
Zimmer Surgical Inc. is recalling 330 units of 30-inch tourniquet cuffs because the instructions for use were missing usage instructions and warnings.
The Apothecary Shoppe is recalling specific vials of Papaverine and Phentolamine Injection because documentation for environmental monitoring during production was missing.
Paleteria La Jalpita is recalling Nance popsicles because they contain undeclared Yellow No. 6, a food dye.
The Apothecary Shoppe is recalling Hydroxyprogesterone Caproate 250 vials due to lack of documentation for environmental monitoring during production.
Siemens Medical Solutions is recalling Artis Q angiography systems because liquid may seep through the top cover, potentially disabling table movements. No injuries have been reported.
The Apothecary Shoppe is recalling SIU-Tri-Mix 18/1/20 Injection because documentation for environmental monitoring during production was missing.
Paleteria La Jalpita is recalling 420 units of Limon (Lemon) Bolis in Oregon and Washington due to undeclared Yellow No. 5.
Paleteria La Jalpita is recalling 945 units of La Jalpita brand mango popsicles distributed in Oregon and Washington due to undeclared Yellow No. 6.
Siemens Medical Solutions is recalling specific Biograph 6-4R CT systems because they may be missing a locking ring on optional ceiling mounts.
The Apothecary Shoppe LLC is recalling SIH-Testosterone Cypionate Injection because proper environmental monitoring documentation is missing, raising concerns about sterility.
The Apothecary Shoppe is recalling S-methylcobalamin 25 mg/mL injection vials because documentation for environmental monitoring during production was missing.
Paleteria La Jalpita is recalling Pepino c/ Chile popsicles due to undeclared Yellow No. 5. The product was distributed in Oregon and Washington.
The Apothecary Shoppe is recalling HCG 1000 U/mL Injection vials because proper environmental monitoring documentation was missing during production.
Atrium Medical Corporation is recalling 620 units of 36Fr Right Angled Firm PVC Thoracic Catheters due to incorrect labeling on inner pouches.
Paleteria La Jalpita is recalling Vanilla popsicles due to undeclared Yellow No. 5 and Yellow No. 6.
Siemens Medical Solutions is recalling three Biograph mCT Flow Edge-4R systems because they may be missing a locking ring on optional ceiling mounts.
The Apothecary Shoppe is recalling SIU-Tri-Mix Injection Solution because proper environmental monitoring documentation was missing during production.